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Co-HLM: Cerebral Oxymetry at Elective Coronary and Valve Surgery.

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01940874
Collaborator
(none)
54
Enrollment
1
Location
24.9
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to decreased cerebral flow and oxygenation in individual patients and this can be detected by means of cerebral oxymetry.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    54 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cerebral Oxymetry at Elective Coronary and Valve Surgery: An Observational Study Using Norepinephrine to Maintain Arterial Blood Pressure on Cardio Pulmonary Bypass.
    Study Start Date :
    Feb 1, 2011
    Actual Primary Completion Date :
    Mar 1, 2013
    Actual Study Completion Date :
    Mar 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Cerebral oximetry

    Outcome Measures

    Primary Outcome Measures

    1. Cerebral oxymetry values [March 2013]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient age under 80.

    • Patients should undergo elective coronary artery bypass grafting surgery (ACB) or heart valve surgery (AVR or MVR).

    • The patient must be admitted at least 18 years of years.

    Exclusion Criteria:

    • Damage to the frontal lobes corresponding to the area where SCO2 monitored.

    • Patients in pharmacological studies.

    • Patients with known intracranial vascular anomalies or cerebral aneurysms.

    • Patients with known neurological disease.

    • Patients with known undergone cerebral insult, TIA or carotid stenosis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oslo University Hospital Oslo Norway 0424

    Sponsors and Collaborators

    • Oslo University Hospital

    Investigators

    • Principal Investigator: Ove A. Hagen, MD, Oslo Ùniversity Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT01940874
    Other Study ID Numbers:
    • 2010/823
    First Posted:
    Sep 12, 2013
    Last Update Posted:
    Oct 9, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Oslo University Hospital
    Cerebral Oximetry.
    Aortic valve stenosis.
    Aortic valve regurgitation.
    Coronary artery disease.
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease
    Aortic Valve Stenosis
    Aortic Valve Insufficiency

    Study Results

    No Results Posted as of Oct 9, 2013